Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis

被引:15
作者
Moreau, Philippe [1 ]
Dimopoulos, Meletios A. [2 ]
Richardson, Paul G. [3 ]
Siegel, David S. [4 ]
Cavo, Michele [5 ]
Corradini, Paolo [6 ]
Weisel, Katja [7 ]
Delforge, Michel [8 ]
O'Gorman, Peter [9 ]
Song, Kevin [10 ]
Chen, Christine [11 ]
Bahlis, Nizar [12 ]
Oriol, Albert [13 ]
Hansson, Markus [14 ]
Kaiser, Martin [15 ]
Anttila, Pekka [16 ,17 ]
Raymakers, Reinier [18 ]
Joao, Cristina [19 ,20 ]
Cook, Gordon [21 ]
Sternas, Lars [22 ]
Biyukov, Tsvetan [23 ]
Slaughter, Ana [23 ]
Hong, Kevin [22 ]
Herring, Jennifer [22 ]
Yu, Xin [22 ]
Zaki, Mohamed [22 ]
San-Miguel, Jesus [24 ]
机构
[1] Univ Hosp Hotel Dieu, Nantes, France
[2] Univ Athens, Athens, Greece
[3] Dana Farber Canc Inst, Boston, MA 02115 USA
[4] Hackensack Univ, John Theurer Canc Ctr, Med Ctr, Hackensack, NJ USA
[5] Bologna Univ, Sch Med, Bologna, Italy
[6] Univ Milan, Fdn IRCCS Ist Nazl Tumori, Milan, Italy
[7] Univ Hosp Tuebingen, Tubingen, Germany
[8] Univ Hosp Leuven, Leuven, Belgium
[9] Univ Coll Dublin, Mater Misericordiae Univ Hosp, Dublin, Ireland
[10] Vancouver Gen Hosp, Vancouver, BC, Canada
[11] Princess Margaret Hosp, Toronto, ON, Canada
[12] Univ Calgary, Tom Baker Canc Ctr, Calgary, AB, Canada
[13] Hosp Badalona Germans Trias & Pujol, Inst Josep Carreras, Inst Catala Oncol, Barcelona, Spain
[14] Lund Univ, Skane Univ Hosp, Lund, Sweden
[15] Royal Marsden Hosp, Surrey, England
[16] Univ Helsinki, Helsinki, Finland
[17] Helsinki Univ Hosp, Comprehens Canc, Helsinki, Finland
[18] Univ Med Ctr Utrecht, Utrecht, Netherlands
[19] NOVA Univ, Champalimaud Fdn Unknown, Hematooncol Dept, Lisbon, Portugal
[20] NOVA Univ, Fac Ciencias Med, Lisbon, Portugal
[21] St James Univ Hosp, St Jamess Inst Oncol, Leeds, W Yorkshire, England
[22] Celgene Corp, Summit, NJ USA
[23] Celgene Int Sarl, Boudry, Switzerland
[24] Clin Univ Navarra, CIMA, IDISNA, Pamplona, Spain
关键词
dexamethasone; pomalidomide; pooled analysis; relapsed and refractory multiple myeloma; safety; CONSENSUS STATEMENT; RENAL IMPAIRMENT; LENALIDOMIDE; BORTEZOMIB; EFFICACY; SAFETY; MM-003;
D O I
10.1111/ejh.12903
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
ObjectivesHeavily pretreated patients with relapsed and refractory multiple myeloma are susceptible to treatment-related adverse events (AEs). Managing AEs are important to ensure patients continue therapy long enough to receive the best clinical benefit. Data from the MM-002, MM-003, and MM-010 trials were pooled to further characterize the safety profile of pomalidomide plus low-dose dexamethasone and AE management. MethodsThis analysis included 1088 patients who received 2 prior therapies, including lenalidomide and bortezomib, and progressed 60days of last therapy. Patients received 28-day cycles of pomalidomide 4mg/day on days 1-21 and low-dose dexamethasone 40mg (20mg if aged > 75years) weekly until disease progression or unacceptable toxicity. Thromboprophylaxis was required. ResultsThe most common grade 3/4 AEs were neutropenia (56.2%), anemia (32.3%), and thrombocytopenia (25.8%), which occurred within the first few cycles of treatment. Grade 3/4 infections occurred in 33.7% patients, of whom 13.9% had pneumonia, and 40.3% had neutropenia. Pomalidomide dose reductions or interruptions were reported in 24.2% and 66.0% of patients, respectively. AEs were managed by dose modifications and/or supportive care. ConclusionsPomalidomide plus low-dose dexamethasone showed an acceptable safety profile, and AEs were well managed according to study protocols and established guidelines.
引用
收藏
页码:199 / 206
页数:8
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